Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection
Primary Purpose
Impotence
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
tadalafil
tadalafil
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Impotence
Eligibility Criteria
Inclusion Criteria:
- History of erection problems
- Anticipate a monogamous female sexual relationship
- Abstain from other erection treatments at least 4 weeks before first dose and throughout the study
- Must be able to make required sexual intercourse attempts
Exclusion Criteria:
- Other primary sexual disorders
- History of radical prostatectomy or other pelvic surgery that affected being able to have an erection
- History of penile implant or clinically significant penile deformity
- Nitrate use
- Certain heart problems
Sites / Locations
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak to your personal physician.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
2
3
1
Arm Description
10 mg tadalafil tablet
20 mg tadalafil tablet
placebo tablet
Outcomes
Primary Outcome Measures
IIEF Erectile Function Domain score from Questions 1-5 and 15. SEP Diary responses to Questions 2-3 and the entire Diary for baseline and endpoint scores.
Secondary Outcome Measures
IIEF questions and scores, Global Assessment Questions, Patient's SEP Diary
Full Information
NCT ID
NCT00547573
First Posted
October 18, 2007
Last Updated
October 18, 2007
Sponsor
Eli Lilly and Company
Collaborators
ICOS Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00547573
Brief Title
Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection
Official Title
A Multinational, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil Administered "On Demand" to Asian Men With Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
Collaborators
ICOS Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study to determine if tadalafil works better than placebo for Asian men having trouble getting or keeping an erection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impotence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
367 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
10 mg tadalafil tablet
Arm Title
3
Arm Type
Active Comparator
Arm Description
20 mg tadalafil tablet
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
placebo tablet
Intervention Type
Drug
Intervention Name(s)
tadalafil
Other Intervention Name(s)
LY450190, Cialis, IC351
Intervention Description
10 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
Intervention Type
Drug
Intervention Name(s)
tadalafil
Other Intervention Name(s)
LY450190, Cialis, IC351
Intervention Description
20 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo tablet taken by mouth as needed for 12 weeks not more than once a day
Primary Outcome Measure Information:
Title
IIEF Erectile Function Domain score from Questions 1-5 and 15. SEP Diary responses to Questions 2-3 and the entire Diary for baseline and endpoint scores.
Time Frame
4, 8, and 12 weeks
Secondary Outcome Measure Information:
Title
IIEF questions and scores, Global Assessment Questions, Patient's SEP Diary
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of erection problems
Anticipate a monogamous female sexual relationship
Abstain from other erection treatments at least 4 weeks before first dose and throughout the study
Must be able to make required sexual intercourse attempts
Exclusion Criteria:
Other primary sexual disorders
History of radical prostatectomy or other pelvic surgery that affected being able to have an erection
History of penile implant or clinically significant penile deformity
Nitrate use
Certain heart problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, ESt)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak to your personal physician.
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection
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